Pharmacelsus

G(C)LP & non-GLP Bioanalytic-Services

The Pharmacelsus bioanalytic team performs highest quality analyses with latest edge technology. We support our in house in vitro and in vivo studies as well as external preclinical and clinical studies with diligence and dedication.

Go for robust and reliable data for your preclinical and clinical projects!

MS Equipment

  • UHPLC-MS/MS Quadrupole OrbitrapTM
  • UHPLC-MS/MS OrbitrapTM
  • 2 LC-MS/MS Triple Quadrupole

Compound Classes

  • Small Molecules
  • Peptides
  • Lipids
  • Plant-extracts
  • Oligo-and polymers

Sample Types

  • Blood, plasma (any species)
  • Tissues (including fat and skin)
  • Urine, faeces, bile
  • Cell culture medium
  • Liquid preclinical dosage forms
  • Others (please contact us)

Quantification of Compounds

  • In body fluids
  • In tissues
  • In samples (non-clinical and clinical)

Quantification of Metabolites

  • In body fluids
  • In tissues
  • In samples (non-clinical and clinical)

Metabolite Identification

  • In vitro and in vivo samples
  • Major metabolites
  • Proposed metabolic pathway
  • Proposed chemical metabolite structure
  • MS/MS-fragment analysis
  • Accurate mass

Quantification of Biomarkers

  • e.g. Bile acids in clinical and non-clinical samples
  • Please contact us for your specific biomarkers

G(C)LP Bioanalytics

Method Development Sample Preparation

  • Protein precipitation, liquid extraction, solid phase extraction (SPE)
  • Optimisation
  • Pre-validation:
    • Test for purity
    • Check for robustness
    • Determine recovery
    • Check for matrix effects

Method Development LC-MS

  • Choose chromatographic method:
    MS-Technology (triple quadrupole MS or high resolution MS)
  • Optimisation
  • Definition of calibration range
  • Pre-validation:
    • Robustness of chromatography
    • Test for selectivity by MS Check for matrix effects

GLP Validation Sample Preparation

  • Test sample stability (storage in frozen state, handling in liquid state)
  • Test analytical samples stability (storage in autosampler and freezer)
  • Test matrix effects (robustness of methods and selectivity with at least six individual matrices)
  • Determine recovery

GLP Validation LC-MS

  • Performance of at least three validation batches:
    • Calibration curve
    • Intra -/inter-run accuracy
    • Intra-/inter-run precision
    • Selectivity tests of MS
    • Validate peak form and carry over
    • Validate reinjection procedures

Preclinical GLP Bioanalytics

  • Studies are performed under GLP:
    Pharmacelsus acts as GLP test facility and as test site for multisite studies. QM inspection of all study phases: study plan, experimental phase, retain samples, data processing, reporting and archiving. Application of fully qualified and calibrated equipment Full documentation and work according standard operating procedure (SOP)

Clinical GC(L)P Bioanalytics

  • Close cooperation with the clinical CRO of your choice
  • Maintenance of “chain of custody”
  • QM inspection of all study phases: study plan, experimental phase, retain samples, data processing, reporting and archiving
  • Application of fully qualified and calibrated equipment
  • Full documentation and work according standard operating procedure (SOP)

Instrumentation and Qualification

  • GLP certified laboratory for the categories 8 and 9
  • Mass spectrometer and HPLC:
    • Qualified equipment
    • Regular maintainance
    • Regular calibration
    • Short qualification once per trimester
    • Re-qualification once per year
  • All steps are conducted according to national and international guidelines.

Data / Archiving

  • Further data evaluations using validated software packages (e.g. KineticaTM from Thermo Fisher Scientific, USA) are available.
  • Data are archived according to GLP guidelines
  • GLP retain samples are archived according to “Deutsches Chemikaliengesetz”
  • All steps are conducted according to national and international guidelines.

Please contact us for your specific bioanalytic study!

Dr. Stephanie Urschel
Head of Marketing & Sales
urschel@pharmacelsus.de

Dr. Peter Ehmer
Project Leader Method Validation (GLP)
ehmer@pharmacelsus.de